The Company Begins Strategic Preparations To Support Anticipated Demand And Optimization Of The Acclaim® Fully Implanted Cochlear Implant Opportunity
Six-month follow-up visits are now underway and will continue over the next two months
White Bear Lake, Minnesota–(Newsfile Corp. – September 24, 2025) – Envoy Medical® Inc. (NASDAQ: COCH) (“Envoy Medical”), a hearing health company focused on developing innovative, fully implanted hearing solutions, today announced it is scaling its commercialization planning for the company’s breakthrough investigational Acclaim® fully implanted hearing device, as its pivotal clinical trial continues to build momentum. The Company’s proactive approach reflects its conviction that fully implanted cochlear implants have an opportunity to unlock a significant market opportunity. By accelerating efforts to train and engage in a network of clinical centers, Envoy Medical aims to achieve sufficient capacity to meet anticipated demand once the Acclaim device receives regulatory approval.
Envoy Medical’s pivotal trial is progressing well, with all patients in the first stage having successfully completed their three-month follow-up milestones with no serious adverse events or unanticipated device effects reported. Six-month follow-up visits have begun with additional follow-up visits being completed over the next two months. The Company is now preparing for the next enrollment phase of the trial, which will be conducted at seven U.S. sites, to commence upon FDA approval of the Company’s expansion request.
“We believe our fully implanted Acclaim® cochlear implant, now advancing through pivotal trials, has the potential to unlock a significant, underserved segment of the hearing loss market – individuals who have not pursued or adopted traditional treatment options. The early interest we’re seeing is encouraging, and we are now focused on laying the groundwork to meet that anticipated demand,” said Brent Lucas, Chief Executive Officer of Envoy Medical.
The Company’s commercialization strategy will focus on identifying, training, and solidifying 30-40 sites should FDA regulatory approval be received. Envoy Medical plans to emphasize depth over breadth, prioritizing excellence and building a strong foundation. Assuming typical volumes at similar sites and a healthy price point, the Company believes there would be a relatively quick path to significant top-line growth.
Those interested in becoming potential surgical or audiological sites should contact customerservice@envoymedical.com.
Envoy Medical plans to provide additional updates on its FDA pivotal clinical trial and other topics over the next several months.
